The following data is part of a premarket notification filed by Vega Technologies, Inc. with the FDA for Infrared Ear Thermometer, Model Ir-04mt.
| Device ID | K102934 |
| 510k Number | K102934 |
| Device Name: | INFRARED EAR THERMOMETER, MODEL IR-04MT |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | VEGA TECHNOLOGIES, INC. 11F-13, 100 CHANG-CHUN RD. Taipei, TW 104 |
| Contact | Joseph Lu |
| Correspondent | Joseph Lu VEGA TECHNOLOGIES, INC. 11F-13, 100 CHANG-CHUN RD. Taipei, TW 104 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-04 |
| Decision Date | 2011-01-14 |
| Summary: | summary |